The FDA Center for Tobacco Products (CTP) at one point expected to authorize bottled e-liquids from manufacturers that submitted premarket tobacco applications (PMTAs).
The FDA tobacco center’s Office of Science submitted a memo outlining a plan to speed up review of e-liquids, according to an exclusive story by Alex Norcia in Filter.
The memo, titled “Bundling and Bracketing Approach for Review of ENDS Open E-liquid PMTAs,” described a process to expedite scientific review of PMTAs for e-liquids by grouping products based on characterizing flavors, using a “flavor wheel” first published in a 2019 paper by a group of Dutch scientists. FDA scientific reviewers could have reviewed multiple products by a single manufacturer, and then bridged their conclusions to additional products included in that company’s PMTA.
Jim McDonald – Vaping360.com – 2022-08-10.